Text Size

Early Detection of Lung Cancer Via Bi-plane Correlation Chest Imaging

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00673283
First received: May 4, 2008
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
  Purpose

This project proposes a new method, Bi-plane Correlation Imaging (BCI), for improved detection of subtle lung nodules. In BCI, two digital radiographs of the chest are acquired within a short time interval from slightly different posterior projections. The image data are incorporated into an enhanced Computer-aided Diagnosis (CAD) algorithm in which nodules present in the thoracic cavity are detected by examining the geometrical correlation of the detected signals in the two views. The data are alos viewed stereoscopically for visual diagnosis. The expected high sensitivity/specificity of the method has the potential to change the current state of practice, perhaps leading to a preventive lung cancer screening program for high-risk populations, similar to the mammography screening program currently in place for breast cancer.


Condition Intervention Phase
Lung Cancer
Metastatic Cancer in the Lungs
 Device: bi-plane chest radiography
 Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Detection of Lung Cancer Via Bi-plane Correlation Chest Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • The technique is effective in diagnosing early lung tumors. [ Time Frame: end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The relative performance of BCI with respect to chest radiography and CT for lung cancer detection. [ Time Frame: end of the study ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: April 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: bi-plane chest radiography
Bi-plane radiography of the thorax

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal individuals
  • Individuals with CT-confirmed subtle lung nodules.

Exclusion Criteria:

  • Individuals with acute pulmonary abnormalities or those in poor health conditions will be excluded due to the potential impact on the results as well as difficulty of acquiring the images. Pregnant women will also be excluded to avoid the exposure of the fetus to radiation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673283

Locations
United States, North Carolina
Duke University Medcal Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Ehsan Samei, PhD Duke University
  More Information

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00673283     History of Changes
Other Study ID Numbers: Pro00008644 (2485-07-6R6)
Study First Received: May 4, 2008
Last Updated: January 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
lung cancer
nodules
radiography
CT
Stereoscopy

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013